Systems, devices, and methods for the accurate deployment of an implant in the prostatic urethra

ABSTRACT

Systems, devices, and methods are provided for the delivery of an implant into the prostatic urethra. Embodiments of delivery systems can include a delivery device for insertion into the patient and a proximal control device for use in controlling release of the implant from the delivery device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/433,463, filed Jun. 6, 2019, which is a continuation of InternationalApplication Serial No. PCT/US17/65469, filed Dec. 8, 2017, which claimspriority to and the benefit of U.S. Provisional Application Ser. No.62/432,542, filed Dec. 9, 2016, all of which are incorporated byreference herein in their entireties for all purposes.

STATEMENT OF GOVERNMENT SPONSOR RESEARCH

This invention was made with government support under NIH SBIR Phase IIR44DK112587 awarded by the National Institutes of Health. The governmenthas certain rights in the invention.

FIELD

The subject matter described herein relates to systems, devices, andmethods for delivery or deployment of an implant into the prostaticurethra, more specifically, delivery in an atraumatic andminimally-invasive manner through the tortuous bends of the maleurethra.

BACKGROUND

There are numerous clinical reasons for placement of an implant into theprostatic urethra, such as for treatment of urinary retention associatedwith benign prostatic hyperplasia (BPH), blockages from prostate cancer,bladder cancer, urinary tract injury, prostatitis, bladder sphincterdyssynergia, benign or malignant urethral stricture, and otherconditions for which treatment is desired. Due to the naturally complexand tortuous anatomical geometry, patient-to-patient geometric andtissue variability, and anatomical restrictions associated with thoseconditions, accurate and consistent placement of an implant into theprostatic urethral lumen has proven challenging. Furthermore, complexchallenges are presented in the design and/or fabrication of systemswith sufficient flexibility to deliver such an implant in aminimally-invasive manner. For these and other reasons, needs exist forimproved systems, devices, and methods of implant delivery to theprostatic urethra.

SUMMARY

Provided herein are a number of example embodiments of delivery systemsfor delivering or deploying implants within the prosthetic urethra orother parts of the body, and methods related thereto. Embodiments of thedelivery system can include a delivery device insertable into theprosthetic urethra and a proximal control device coupled with thedelivery device and configured to control deployment of one or moreimplants from the delivery device. In some embodiments, the deliverydevice can include multiple tubular components each having variousfunctions described in more detail herein. Multiple embodiments ofimplants for use with the delivery systems are also described.

Other systems, devices, methods, features and advantages of the subjectmatter described herein will be or will become apparent to one withskill in the art upon examination of the following figures and detaileddescription. It is intended that all such additional systems, methods,features and advantages be included within this description, be withinthe scope of the subject matter described herein, and be protected bythe accompanying claims. In no way should the features of the exampleembodiments be construed as limiting the appended claims, absent expressrecitation of those features in the claims.

BRIEF DESCRIPTION OF THE FIGURES

The details of the subject matter set forth herein, both as to itsstructure and operation, may be apparent by study of the accompanyingfigures, in which like reference numerals refer to like parts. Thecomponents in the figures are not necessarily to scale, emphasis insteadbeing placed upon illustrating the principles of the subject matter.Moreover, all illustrations are intended to convey concepts, whererelative sizes, shapes and other detailed attributes may be illustratedschematically rather than literally or precisely.

FIG. 1A is a block diagram depicting an example embodiment of a deliverysystem.

FIGS. 1B, 1C, and 1D are side, end, and perspective views, respectively,depicting an example embodiment of an implant.

FIGS. 2A-2H are perspective views depicting example embodiments of adelivery system in different stages of deployment of an implant.

FIGS. 3A-3C are perspective views depicting example embodiments of agrasper component in use within a delivery system.

FIGS. 4A-4J are partial cross-sectional views depicting exampleembodiments of anchor delivery members of a delivery system.

FIGS. 5A-5B are side views depicting an example embodiment of a deliverysystem in various stages of deployment of an implant.

FIGS. 6A and 6B are interior side and interior perspective views,respectively, depicting an example embodiment of a proximal controldevice.

FIG. 6C is a perspective view depicting an example embodiment of a gearfor use with the delivery system.

FIG. 7A is an interior top down view depicting an example embodiment ofcomponents of a proximal control device.

FIG. 7B is a perspective view depicting an example embodiment of a cam.

FIG. 8 is an interior side view depicting an example embodiment of agear assembly.

FIGS. 9A-9F are interior perspective views depicting an exampleembodiment of components of a proximal control device.

FIG. 10A is a flowchart depicting an example embodiment of a method fordelivering an implant.

FIG. 10B is a timing diagram depicting an example embodiment of asequence of steps for deploying an implant.

DETAILED DESCRIPTION

Before the present subject matter is described in detail, it is to beunderstood that this disclosure is not limited to the particularembodiments described, as such may, of course, vary. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the present disclosure will be limited onlyby the appended claims.

The subject matter presented herein is described in the context ofdelivery or deployment of one or more implants within the prostaticurethra. The purpose for deployment of the implant(s) in the prostaticurethra can vary. The embodiments described herein are particularlysuited for treatment of BPH, but they are not limited to such. Otherconditions for which these embodiments can be used include, but are notlimited to, treatment of blockages from prostate cancer, bladder cancer,urinary tract injury, prostatitis, bladder sphincter dyssynergia, and/orbenign or malignant urethral stricture. Further, these embodiments canhave applicability for deployment of one or more implants in otherlocations of the urinary tract or in the bladder, as well as otherbiological lumens, cavities, or spaces, such as the human vasculature,cardiac system, pulmonary system, or gastro-intestinal tract, includinglocations within the heart, stomach, intestines, liver, spleen,pancreas, and kidney.

FIG. 1A is a block diagram depicting an example embodiment of deliverysystem 100 having an elongate delivery device 103 coupled with aproximal control device 200. A distal end region 104 is adapted to beinserted into the patient's urethra (or other lumen or body cavity ofthe patient) through the urethral orifice. Distal end region 104preferably has an atraumatic configuration (e.g., relatively soft androunded) to minimize irritation or trauma to the patient. Elongatedelivery device 103 carries or houses one or more implants 102 (notshown) to be delivered or deployed within or adjacent to the prostaticurethra. A proximal end region 105 of delivery device 103 is coupledwith proximal control device 200, which remains outside of the patient'sbody and is configured to be used by the physician or other healthcareprofessional to control the delivery of one or more implants 102.

Example Embodiments of Delivery Devices and Related Methods

FIGS. 1B, 1C, and 1D are side, end, and perspective views, respectively,depicting an example embodiment of implant 102 in an at-restconfiguration. Implantable device 102 is biased towards the at-restconfiguration depicted here and is deformable between the at-restconfiguration and a relatively more elongate housed (or delivery)configuration (e.g., see FIG. 3A) for housing implant 102 withindelivery device 103. The housed configuration can be a straight orlineated state with minimal curvature. The at-rest configuration has arelatively greater lateral width, and a relatively shorter longitudinallength than the housed configuration. Upon exiting an open end ofdelivery device 103, implant 102 is free to transition its shape backtowards that of the at-rest configuration although restraints impartedby the patient's urethral wall may prevent implant 102 from fullyreaching the at-rest configuration. Because implant 102 is biasedtowards the at-rest configuration, implant 102 is configured toautomatically expand when freed from the restraint of delivery device103 and can be referred to as “self-expanding.” The shape of implant 102in its deployed state within, e.g., the patient's urethra, can bereferred to as the deployed configuration, and will often be a shapethat is deformed from the at-rest configuration by the surroundingtissue, although the deployed configuration can be the same as theat-rest configuration.

Implant 102 can be configured in numerous different ways, including anyand all of those implant configurations described in U.S. Patent Publ.No. 2015/0257908 and/or Int'l Publ. No. WO 2017/184887, both of whichare incorporated by reference herein for all purposes.

Implant 102 can be formed from one or more discrete bodies (e.g., wires,ribbons, tubular members) of varying geometries. Referring to theembodiment of FIGS. 1B-1D, implant 102 has a main body formed of onlyone single wire member set in a predetermined shape. Implant 102 canhave two or more ring-shaped structures 111 (in this embodiment thereare four: 111 a, 111 b, 111 c, and 111 d) with one or moreinterconnections 112 extending between each pair of adjacent ring-shapedstructures 111 (in this embodiment there is one interconnection betweeneach adjacent pair, for a total of three: 112 a, 112 b, and 112 c). Eachinterconnection 112 extends from one ring-shaped structure 111 to animmediately adjacent ring-shaped structure 111. Each interconnection 112can have a relatively straight shape (not shown) or a curved (e.g.,semi-circular or semi-elliptical) shape as shown in FIGS. 1B-1D.

Ring-shaped structures 111 are configured to maintain the urethra in afully or partially open state when expanded from the housedconfiguration. Device 100 can be manufactured in various sizes asdesired, such that the width (e.g., diameter) of each ring-shapedstructure 111 is slightly larger than the width of the urethra, and thelength of each interconnection 112 determines the spacing betweenring-shaped structures 111. Ring-shaped structures 111 can have the sameor different widths. For example, in the embodiment depicted here,ring-shaped structure 111 a has a relatively smaller width thanstructures 111 b-111 d, which have the same width. This can accommodateprostatic urethras that converge to a smaller geometry before thebladder neck.

Each ring-shaped structure 111 can be located or lie in a single plane,and in some embodiments that single plane can be oriented with a normalaxis perpendicular to a central access 124 of implant 102 (as depictedin FIG. 1B). In other embodiments, ring-shaped structures 111 can belocated in multiple planes. Ring-shaped structures 111 can extend aroundcentral axis 126 to form a complete circle (e.g., a 360-degreerevolution) or can form less than a complete circle (e.g., less than 360degrees) as shown here. Although not limited to such, in manyembodiments ring-shaped structures 111 extend between 270 and 360degrees.

As can be seen from FIGS. 1B-1D, the geometry of implant 102 can have acylindrical or substantially cylindrical outline shape with a circularor elliptical cross-section. In other embodiments, implant 102 can havea prismatic or substantially prismatic shape with triangular orsubstantially triangular cross-section, or otherwise.

Implant 102 can also include a distal engagement member 114 and aproximal engagement member 115 that are each configured to engage withelements of delivery device 103. Engagement with delivery device 103 canserve one or more purposes such as allowing control of the release ofimplant 102, allowing movement of the ends of implant 102 relative toeach other, and/or allowing retrieval of implant 102 after deployment,e.g., in an instance where the physician desires to recapture implant102 and redeploy implant 102 in a different position. In thisembodiment, distal engagement member 114 is a wire-like extension fromring-shaped structure 111 a that has a curved (e.g., S-like) shape forpositioning an atraumatic end 116 (e.g., rounded, spherical, ballized)in a location suitable for engagement with delivery device 103 andthereby allow control of the distal end region of implant 102. Likewise,proximal engagement member 115 has a curved shape for positioninganother atraumatic end 117 in a location suitable for engagement withdelivery device 103 and thereby allow control of the proximal end regionof implant 102. In other embodiments, distal engagement member 114 andproximal engagement member 115 can be omitted, and delivery device 103can couple with implant 102 at one or more other distal and/or proximallocations, such as on a ring-shaped structure 111 or interconnect 112.

Delivery device 103 can include one or more elongate flexible members(e.g., 120, 130, 140, and 150 as described below), each having one ormore inner lumens. One or more elongate flexible members of deliverydevice 103 can be a solid or a non-hollow member with no inner lumen.FIG. 2A is a perspective view depicting an example embodiment of distalend region 104 of a delivery device 103. In this embodiment, deliverydevice 103 includes a first elongate tubular member 120, a secondelongate tubular member 130, a third elongate tubular member 140, and afourth elongate tubular member 150. Delivery device 103 can vary and inother embodiments can include more or less tubular members.

In this embodiment, first elongate tubular member 120 is the outermosttubular member and is flexible yet provides support for memberscontained therein. First tubular member 120 is referred to herein asouter shaft 120 and can have one or more inner lumens. In thisembodiment, outer shaft 120 includes a first inner lumen 121 housingsecond elongate tubular member 130, which is referred to herein as innershaft 130. Outer shaft 120 and inner shaft 130 are each controllableindependent of the other. Inner shaft 130 can slide distally andproximally within lumen 121 and is shown here partially extending froman open distal terminus of outer shaft 120.

In this embodiment, outer shaft 120 includes three additional lumens122, 123, and 124. An illumination device (not shown) and an imagingdevice (not shown) can be housed in either of lumens 122 and 123. Theimaging device can utilize any desired type of imaging modality, such asoptical or ultrasound imaging. In one example embodiment the imagingdevice utilizes a forward (distal) looking CMOS imager. The illuminationdevice can be configured to provide adequate illumination for opticalimaging, and in one embodiment includes one or more light emittingdiodes (LEDs). In embodiments where illumination is not required, suchas for ultrasound imaging, the illumination device and its respectivelumen 122 or 123 can be omitted. The illumination device and/or theimaging device can each be fixedly secured at the distal terminuses oflumens 122 and 123, or each can be slidable within lumens 122 and 123 toallow advancement further distally from outer shaft 120 and/orretraction into outer shaft 120. In one example embodiment, theillumination device and the imaging device are mounted together and onlya single lumen 122 or 123 is present for that purpose. Lumen 124 can beconfigured as an irrigation or flush port from which fluid such assaline can be introduced to the urethra to flush the region and provideadequate fluid through which implant 102 and the surrounding prostaticurethra wall can be imaged.

Outer shaft 120 has a proximal end (not shown) coupled with proximalcontrol device 200. Delivery device 103 can be configured to besteerable to navigate tortuous anatomy. Steerability can beunidirectional (e.g., using a single pull wire) or multidirectional(e.g., using two or more pull wires arranged at different radiallocations about device 103) depending on the needs of the application.In some embodiments, the structures (e.g., pull wires) for steerabilityextend from distal end region 104 of delivery device 103 (e.g., wherethe distal ends of the pull wires are secured to a plate or otherstructure within distal end region 104) to proximal control device 200,where they can be manipulated by the user to steer delivery device 103.The steering structures can be located in one or more lumens of outershaft 120 or can be coupled to or embedded within a sidewall of outershaft 120. Delivery device 103 can be biased to deflect in a particularlateral direction (e.g., bend) such that device 103 automaticallydeflects in that manner and forces imparted to steer delivery device 103are in opposition to this biased deflection. Other mechanisms forsteering delivery device 103 can also be used. The steering mechanismmay also be locked or adjusted during deployment of implant 102 tocontrol the position of implant 102 within the anatomy (e.g., steeringanteriorly during deployment may help place implant 102 in a moredesirable anterior position).

Inner shaft 130 can include one or more inner lumens for housing one ormore implants 102 and/or other components. In this embodiment, innershaft 130 includes a first lumen 131 in which one or more implants 102can be housed, and a second lumen 132 in which third elongate tubularmember 140 can be housed. In this embodiment, third elongate tubularmember 140 is configured to releasably couple with the distal end regionof implant 102 and is referred to as a distal control member or tether140. Distal control member 140 can be slidably advanced and/or retractedwith respect to inner shaft 130. Distal control member 140 can includean inner lumen 141 that houses fourth elongate tubular member 150, whichis shown here extending from an open distal terminus of distal controlmember 140. Fourth elongate tubular member 150 is configured to anchordelivery device 103 with respect to the patient's anatomy, e.g., to keepcomponents of delivery device 103 stationary with respect to the anatomyduring deployment of implant 102 and is referred to as anchor deliverymember 150.

In the configuration depicted in FIG. 2A, anchor delivery member 150 isextended from lumen 141 of distal control member 140, and distal controlmember 140 along with inner shaft 130 are shown extended from lumen 121of outer shaft 120. When delivery device 130 is advanced through theurethra, anchor delivery member 150 is preferably housed entirely withindistal control member 140, and distal control member 140 along withinner shaft 130 are retracted from the positions shown in FIG. 2A suchthat they reside within lumen 121 of outer shaft 120 and do not extendfrom the open distal terminus of lumen 120. In other words, in someembodiments the open distal terminus of outer shaft 120 forms thedistalmost structure of device 103 upon initial advancement through theurethra. This facilitates steering of delivery device 103 by outer shaft120. The physician can advance distal end region 104 of delivery device103 to be in proximity with the desired implantation site, or entirelyinto the patient's bladder. Anchor delivery member 150 can be exposedfrom the open distal terminus of distal control member 140, either bydistally advancing anchor delivery member 150 further into the bladder,or if already present within the bladder, then by proximally retractingthe other components of delivery device 103. At this point the anchorfrom anchor delivery member 150 can be deployed in the bladder.

The placement of these components within system 100 is not limited tothe embodiments described with respect to FIG. 2A. In some embodiments,outer shaft 120 can be omitted altogether. In such embodiments,visualization of the deployment procedure can be accomplished withexternal imaging such as fluoroscopy, where implant 102 and deliverydevice 103 can be radiopaque or can include radiopaque markers, andwhere the imaging and illumination lumens 122 and 123 (and the imagingand illumination devices), as well as the irrigation lumen are omitted.In some embodiments, instead of distal control member 140 being slidablyreceived within inner shaft 130, distal control member 140 can beslidable within a lumen of outer shaft 120 (either the same lumenreceiving inner shaft 130 or a different lumen). Similarly, instead ofanchor delivery member 150 being slidably received within distal controlmember 140, anchor delivery member 150 can be slidable within a lumen ofouter shaft 120 (either the same lumen receiving inner shaft 130 and/oranchor delivery member 150 or a different lumen) or a lumen of innershaft 130 (either the same lumen receiving distal control member 140 ora different lumen). In some embodiments, outer shaft 130 has a separateand distinct lumen for each of members 130, 140, and 150, and can beconfigured to deploy implant 102 around members 140 and 150.

FIG. 2B is a perspective view depicting distal end region 104 ofdelivery device 103 with the various components deployed. In thisembodiment, anchor delivery member 150 includes an anchor 152 in theform of an inflatable member or balloon. Other embodiments of anchors152 are described with respect to FIGS. 4A-4G. Anchor 152 expands (orotherwise transitions) to a size greater than that of the bladder necksuch that anchor 152 resists proximal retraction (e.g., a relativelylight tension). In embodiments where anchor 152 is a balloon, thatballoon can be elastic or inelastic and inflatable with an inflationmedium (e.g., air or liquid such as saline) introduced into balloon 152through one or more inflation ports 153. Here three inflation ports 153are located on the shaft of anchor delivery member 150 and communicatewith an inflation lumen that extends proximally back to proximal controldevice 200, which can include a port for inflation with a syringe. Upondeployment of anchor 152, the physician can proximally retract deliverysystem 100 until anchor 152 is in contact with the bladder neck and/orwall (if not already).

The physician can use the imaging device of outer shaft 120 to movedelivery device 103 proximally away from anchor 152 until the physicianis in the desired position within the urethra to begin deployment ofimplant 102. A retainer 142 on distal control member 140 is releasablycoupled with distal engagement member 114 of implant 102. The physiciancan position retainer 142 in a location along the length of the urethrawhere the physician desires the distal end of implant 102 to deploy.This can involve moving distal control member 140 and inner shaft 130,together, proximally and/or distally with respect to anchor deliverymember 150. In another embodiment, the position of retainer 142 is fixedwith respect to anchor 152 such that the longitudinal position ofimplant 102 within the anatomy is set by the system independently of anymanipulation by the physician. The coupling of distal engagement member114 with retainer 142 also permits the physician to manipulate theradial orientation of implant 102 by rotating distal control member 140and inner shaft 130 together. Active or passive shaping of distalcontrol member 140 may allow for a more desirable placement of implant102. For example, member 140 may have a curvature that places theimplant in a more anterior anatomical position. This curvature may beinherently set in member 150 or actively applied by the physician thougha separate entity such as a control wire. Once in the desired locationand orientation, the physician can proximally retract inner shaft 130with respect to distal control member 140 to initiate deployment ofimplant 102.

Distal engagement member 114 is held in place with respect to distalcontrol member 140 by retainer 142, and proximal retraction of innershaft 130 with respect to distal control member 140 causes ring-shapedstructures 111 to begin to deploy in sequence (111 a, then 111 b, then111 c, then 111 d (not shown)). Distal control member 140 can remainstationary or be moved longitudinally with respect to the urethra duringdeployment. In some embodiments, distal control member 140 is steerableto allow for angulation of implant 102 to accommodate relativelytortuous anatomy. Mechanisms for accomplishing steerability arediscussed elsewhere herein and can likewise be applied to distal controlmember 140. In these or other embodiments, distal control member 140 canbe significantly flexible to passively accommodate tortuous anatomy. Insome embodiments, distal control member 140 has a predefined curve toassist in navigation.

To assist in deployment, inner shaft 130 can rotate clockwise andcounterclockwise (as depicted by arrow 134) about distal control member140. Referring back to FIGS. 1B-1C, implant 102 has a non-constantdirection of winding that, when viewed as commencing at distalengagement member 114, proceeds clockwise along ring-shaped structure111 a, then reverses along interconnect 112 a to a counterclockwisedirection for ring-shaped structure 111 b, then reverses alonginterconnect 112 b to a clockwise direction for ring-shaped structure111 c, and then reverses along interconnect 112 c to a counterclockwisedirection for ring-shaped structure 111 d, until ending at proximalengagement member 115. Depending on the direction of winding of theportion of implant 102 about to exit the open distal terminus of lumen131, the transition of implant 102 towards the at-rest configuration canimpart a torque on shaft 130 if shaft 130 is not actively rotated asimplant 102 is deployed. That torque can cause shaft 130 to passivelyrotate (without user intervention) either clockwise or counterclockwiseaccordingly. In certain embodiments described elsewhere herein, shaft130 is actively rotated during deployment. Rotation of inner shaft 130with respect to distal control member 140 thus allows delivery device103 to rotate and follow the direction of winding of implant 102. Insome embodiments, all ring-shaped structures 111 are wound in the samedirection, clockwise or counterclockwise (e.g., as in the case of afully spiral or helical implant), or do not have a set direction ofwinding.

In this or other embodiments, the distal end region of inner shaft 130is configured to be relatively more flexible than the more proximalportion of inner shaft 130, which can permit avoidance of excessivemotion of the rest of device 103 during deployment, resulting in bettervisualization and less tissue contact by device 103. Such aconfiguration can also reduce the stress imparted on implant 102 bydevice 103 during delivery. For example, the portion of inner shaft 130extending from outer shaft 120 during deployment can be relatively moreflexible than the portion of inner shaft 130 that remains within outershaft 120, thus allowing inner shaft 130 to flex more readily as implant102 exits inner lumen 131. This in turn can stabilize delivery device103 and allow the physician to obtain stable images of the appointmentprocess.

FIG. 2B depicts implant 102 after three ring-shaped structures 111 a,111 b, and 111 c have been deployed. Proximal retraction of shaft 130continues until the entirety of implant 102, or at least all ofring-shaped structures 111, have exited lumen 131. If the physician issatisfied with the deployed position of implant 102 and the deployedshape of implant 102, then implant 102 can be released from deliverydevice 103.

Release of the distal end of implant 102 can be accomplished byreleasing retainer 142. Retainer 142 can be a cylindrical structure orother sleeve that linearly or rotationally actuates over a cavity orrecess in which a portion of implant 102 is housed. In the embodiment ofFIG. 2B, retainer 142 includes an opening or slot that allows distalengagement member 114 to pass therethrough. Retainer 142 can rotate withrespect to the cavity or recess in which distal engagement member 114(not shown) is housed until the opening or slot is positioned overmember 114, at which point member 114 is free to release from distalcontrol member 130. Rotation of retainer 142 can be accomplished byrotation of a rotatable shaft, rod or other member coupled with retainer142 (and accessible at proximal control device 200).

FIGS. 2C and 2D are perspective views depicting another exampleembodiment of system 100 with a different embodiment of retainer 142shown in more detail. Here, retainer 142 slides distally and/orproximally with respect to distal control member 140. Distal engagementmember 114 of implant 102 can be received within a corresponding recessof distal control member 140. Retainer 142 can slide over distalengagement member 114 while received within this recess until retainer142 abuts a stepped portion of member 140. A control wire 146 extendswithin the length of control member 140, either in the same lumen asanchor delivery member 150 or in a different lumen. Control wire 146couples with retainer 142 with an enlarged portion 147 from whichcontrol wire 146 can be routed into member 140 through an opening 148.

Engagement member 114 can be placed within the recess and retainer 142can be advanced over engagement 114 to secure the distal end of implant102 to control member 140. Upon satisfactory deployment of implant 102within the urethra, e.g., in the state of FIG. 2C, retainer 142 can beproximally retracted with control wire 146 to expose engagement member114 and permit its release from member 140. FIGS. 2E and 2F areperspective views depicting another embodiment of system 100 withanother configuration for retainer 142 that operates in similar fashionto that described with respect to FIGS. 2C and 2D. Here, implant 102 isnot shown and recess 143 in which distal engagement member 114 can bereceived is shown in more detail.

FIGS. 2G and 2H are side and perspective views, respectively, of anotherexample embodiment of system 100. In this embodiment, inner shaft 130includes a flexible distal extension 160 in which inner lumen 131 (notshown) is located. In this configuration, the open distal terminus oflumen 131 is located distal to the open distal terminus of lumen 132(not shown) from which distal control member 140 extends. Lumens 122,123, and 124 (not shown) are located on outer shaft 120 opposite todistal extension 160. Flexible distal extension 160 contributes to theflexibility to stabilize the delivery system, as well as to stabilizethe image. Flexible extension 160 helps align ring-shaped structures 111in a planar manner, and helps vector implant 102 (e.g., point radially)toward the urethral wall during deployment.

Release of the proximal end of implant 102 is also controllable. FIG. 3Ais a partial cross-sectional view depicting an example embodiment ofsystem 100 with a portion of implant 102 shown within inner lumen 131 ofinner shaft 130. Here, implant 102 is in the lineated state prior todeployment with proximal engagement member 115 coupled with a grasper136 that is slidable distally and/or proximally within lumen 131.Grasper 136 can include a distal end region 137 on or coupled with ashaft 138. Grasper 136 is preferably controllable to rotate andlongitudinally translate (e.g., push and pull) implant 102 with respectto inner shaft 130.

FIGS. 3B and 3C are perspective views depicting an example embodiment ofdistal end region 137 of grasper 136 without implant 102 and withimplant 102, respectively. Grasper 136 includes a recess (also referredto as a cavity or pocket) 139 for receiving and holding proximalengagement member 115. Here, the enlarged portion 117 is retained withinrecess 139 by a distal necked down region having a relatively smallerwidth. While within inner lumen 131, the sidewalls of inner shaft 130maintain proximal engagement member 115 within recess 139. When distalend region 137 exits inner lumen 131 (either by retracting inner shaft130 with respect to grasper 136 or by advancing grasper 136 with respectto inner shaft 130), the restraint imparted by the inner shaft sidewallsis no longer present and engagement member 115 is free to release fromgrasper 136. Thus, when the physician is satisfied with placement of thedeployed implant 102, distal engagement member 114 can be released bymoving retainer 142 and permitting distal engagement member 114 todecouple from control member 140, and proximal engagement member 115 canbe released by exposing grasper 136 from within inner shaft 130 andpermitting proximal engagement member 115 to decouple from grasper 136.

Grasper 136 can also assist in loading implant 102. In some embodiments,application of a tensile force on implant 102 with grasper 136 (whilethe opposite end of implant 102 is secured, for example, by retainer142) facilitates the transition of implant 102 from the at-restconfiguration to a lineated configuration suitable for insertion ofimplant 102 into inner shaft 130.

Anchor delivery member 150 can have multiple different configurationsand geometries (e.g., including those that extend in one directionacross the bladder wall, two directions across the bladder wall (e.g.,left and right), or three or more directions across the bladder wall).FIGS. 4A-4B are cross-sectional views depicting an example embodiment ofanchor delivery member 150 in various stages of deployment within apatient's body. In FIG. 4A, anchor delivery member 150 has been advancedthrough urethra 401 until open distal end 151 is past the bladder neckand within bladder 402, although in this and other embodiments end 401can be stopped prior to entering bladder 402. Here, two anchoring arms408 a and 408 b are housed within an inner lumen of anchor deliverymember 150. In other embodiments, anchoring arms 408 can each be housedin a separate lumen within member 150. Anchoring arms 408 can bedistally advanced with respect to anchor delivery member 150 (or anchordelivery member 150 can be advanced into bladder 402 and proximallyretracted with respect to anchoring arms 408) such that upon exitingopen distal end 151, deflectable portions 410 a and 410 b transitionlaterally into contact with the bladder wall forming anchor 152 asdepicted in FIG. 4B.

Anchoring arms 408 can be formed of a shape retentive material that isbiased towards the at-rest configuration of FIG. 4B. The distal ends ofanchoring arms 408 can each have an atraumatic terminus as depicted here(e.g., rounded, spherical, ballized) and, or alternatively, the distalends of arms 408 can curve away from the bladder wall for addedatraumatic effect. In other embodiments, only one anchoring arm 408 isused. FIG. 4C is a cross-sectional view depicting another exampleembodiment of anchor delivery member 150. Here, deflectable portions 410a and 410 b have a generally straight or lineated shape and deflect froma shared shaft 412 that is slidable distally and/or proximally withrespect to anchor delivery member 150. In all of the anchoringembodiments described herein, the one or more deflectable portions candeflect from a shared shaft (such as depicted here) or from separateshafts (such as depicted in FIGS. 4A-4B).

FIGS. 4D-4E are partial cross-sectional views depicting another exampleembodiment of anchor delivery member 150. FIG. 4D depicts thisembodiment with anchor 152 in a state of partial deployment from opendistal end 151 of anchor delivery member 150. FIG. 4E depicts anchor 152after full deployment within bladder 402. Here, anchor 152 includeslaterally deflectable struts 420 a, 420 b, 421 a, and 421 b connected byhinges 422 a, 422 b, and 422 c. specifically, laterally deflectablestruts 420 a and 421 a are connected by hinge 422 a, laterallydeflectable struts 420 b and 421 b are connected by hinge 422 b, andstruts 421 a and 421 b are connected by hinge 422 c. Again, anchor 152is biased towards the at-rest configuration depicted in FIG. 4E andautomatically transitions towards this configuration once exposed fromwithin the inner lumen of anchor delivery member 150. Hinges 422 caneach be implemented as a living hinge such as depicted in FIG. 4E, e.g.,defined by a reduced with or relatively more flexible section of thedevice. Other hinge configurations can also be utilized.

In another embodiment, a pull wire or other member 424 is attached toone or more of struts 421 and/or hinge 422 c and extends proximally toproximal control device 200. In FIG. 4E, pull member 424 is shown with adashed line to indicate that it is optional. Proximal retraction of pullmember 424 at proximal control device 200 causes the structuralarrangement to laterally deflect into the configuration depicted in FIG.4E. This arrangement provides a significant locking force while tensionis maintained on pull member 424.

FIG. 4F is a partial cross-sectional view depicting another exampleembodiment of anchor delivery member 150. Here, a shape retentiveelement 430 has been advanced from within the inner lumen of anchordelivery member 150 where it was in a relatively straight or lineatedshape. Upon exiting open distal end 151, the distal portion of element430 automatically transitions towards a laterally expanded shape 432,which in this embodiment is in the shape of a coil or spiral. FIG. 4Gdepicts another example embodiment where the laterally expanded shape432 has multiple loops and resembles a numeral “8” or a bowtie. Manydifferent shapes can be utilized for laterally expanded shape 432 inaddition to those depicted here. In all of the anchoring embodiments,the distal termini of the wires or elements exposed to the body tissuecan have a rounded or enlarged atraumatic end (as depicted in FIGS. 4Fand 4G).

Upon completion of the implant deployment procedure, anchor 152 can becollapsed or retracted to permit removal of delivery device 103. Forinstance, in embodiments where anchor 152 is a balloon, that balloon isdeflated and optionally retracted back into a lumen of device 103, andsubsequently withdrawn from the bladder and urethra. In embodimentswhere anchor 152 is a wire form or other expandable member (such asthose described with respect to FIGS. 4A-4G), anchor 152 is retractedback into the lumen of device 103 from which it was deployed, and device103 can subsequently be withdrawn from the bladder and urethra.Retraction can be accomplished using fluid or pneumatic actuation, ascrew type mechanism, or others.

In FIG. 2B, anchor 152 is a generally spherical balloon with anchordelivery member 150 extending through the center. In other embodiments,balloon anchor 152 can be laterally offset, or positioned on only oneside of anchor delivery member 150. FIG. 4H is a partial cross-sectionalview depicting an example embodiment having a laterally offset balloon152. Here the laterally offset balloon 152 exerts force on the side ofbladder neck 403, and forces anchor delivery member 150 (and deliverydevice 103) in direction 450.

In other embodiments device 103 can include two or more balloons thatcan independently inflate in different lateral directions. Independentinflation of one or more balloons while maintaining the one or moreremaining balloons in a deflated state can allow the user to change theangle of the delivery catheter relative to the anatomy, and thus allowfor deployment of the implant in anatomy with significant curvatures.FIG. 4I depicts another example embodiment where a first anchor balloon152 a is inflated to a larger size than a second anchor balloon 152 blocated on the opposite side of member 150. As a result of the forcesexerted on the bladder wall, member 150 is tilted away from the smallerballoon 152 b in direction 451. Selection of the appropriate balloon orballoons for inflation can be performed by the physician and the processof inflation and deflation can be repeated until the physician achievesa desirable angular orientation of device 103 within the anatomy, atwhich point the rest of the delivery procedure can be performed.Delivery member 150 can be a flexible or rigid shaft pre-shaped in amanner which will not impede the ability of implant 102 to be placed ina desirable anatomical position. For example, curvature in member 150just proximal to the balloon mount location may allow implant 102 to beplaced more anteriorly without constraint from the bladder neck.

In some embodiments, a shaped balloon or substantially elastic ballooncan be inflated at the same location as the bladder neck. FIG. 4Jdepicts an example embodiment where balloon 152 is inflated at bladderneck 403. Here, balloon 152 includes a first lobe 155 formed in bladder402 and a second lobe 156 formed in urethra 401. This configuration canbe used to anchor member 150 directly over bladder neck 403.

Example Embodiments of Proximal Control Devices and Related Methods

FIG. 5A is a side view depicting an example embodiment of deliverysystem 100 prior to deployment of implant 102, and FIG. 5B is a sideview depicting this embodiment with implant 102 in a deployedconfiguration (anchor delivery member 150 and distal control member 140are not shown). In this embodiment proximal control device 200 is ahandheld device having a handle 201, a user actuator 202 (configured inthis example as a trigger), and a main body 203. A longitudinal axis ofdelivery device 103 is indicated by dashed line 204. Proximal controldevice 200 can include mechanisms that are manually powered by actuationof actuator 202 to cause relative motions of the components of device103. In other embodiments, proximal control device 200 can utilizeelectrically powered mechanisms instead.

FIG. 6A is an interior view of proximal control device 200 that depictsvarious mechanical assemblies or subassemblies within a main housing 203of control device 200. In this embodiment, proximal control device 200is configured to perform three types of motion on implant 102, namely,distal advancement of implant 102 along axis 204 (e.g., pushing),proximal retraction of implant 102 and/or inner shaft 130 along axis 204(e.g., pulling), and rotation of inner shaft 130 about axis 204 (e.g.,rotation). In other embodiments, depending on the delivery functionsdesired, proximal control device 200 can be configured to perform anysubset of one or two of the aforementioned types of motion, to performthese types of motion but imparted on different components, or toperform other types of motion not mentioned here.

In this embodiment, proximal control device 200 includes alongitudinally translatable member 601 that, in this embodiment, isconfigured as a yoke. Yoke 601 is coupled with trigger 202 such thatdepression of trigger 202 causes proximal longitudinal translation ofyoke 601. Yoke 601 is coupled with two proximally-located ratchetmembers 602 and 603 that, in this embodiment, are configured as pawls.Pawl 602 has a set of teeth that oppose corresponding teeth on pawl 603,and the teeth of each pawl 602 and 603 can interface or engage withcomplementary teeth on a gear 605 (see FIG. 6B), referred to herein as apinion gear, that is part of a first gear assembly 600.

A switch 604 is accessible to the user and can be shifted between twopositions, where each position is responsible for bringing only one ofpawls 602 and 603 into engagement with pinion gear 605. Each of pawls602 and 603 are deflectable and biased (e.g., with the spring) towardsengagement with pinion gear 605. In this embodiment, placement of switch604 in a downward position moves pawl 602 out of engagement with piniongear 605 and moves pawl 603 into engagement with pinion gear 605. Theproximal movement of yoke 601 and pawl 603 causes pinion gear 605 torotate counterclockwise. Placement of switch 604 in an upward positionreverses the engagement and places pawl 602 into engagement with piniongear 605 and the proximal movement of yoke 601 and pawl 602 causespinion gear 605 to rotate clockwise.

In this embodiment, first gear assembly 600 includes pinion gear 605, asecond gear 610, a third gear 612, and a fourth gear 614. In otherembodiments, first gear assembly 600 can be implemented to achieve thesame or similar functionality with more or less gears than thosedescribed here.

Pinion gear 605 is engaged with second gear 610, which is orientedperpendicular to pinion gear 605. Pinion gear 605 has teeth that projectfrom the radial edge of gear 605 while the second gear 610 has teeththat project from both distal face and a proximal face of the gear 610,which is referred to herein as face gear 610. Counterclockwise rotationof pinion gear 605 will cause rotation of face gear 610 in a firstdirection and clockwise rotation of pinion gear 605 will cause rotationof face gear 610 in a second, opposite direction. The direction ofrotation of face gear 610 in turn determines whether implant 102 isproximally retracted or distally advanced with respect to housing 203.

FIG. 6B is a perspective view depicting the interior of this embodimentof proximal control device 200 in more detail. The proximally facingteeth on face gear 610 engage with teeth on gear 612, referred to as aninput gear. The teeth of input gear 612 are engaged with teeth of gear614. Gear 614 is coupled with, or integrated with, a reel 616 that isconfigured to house or hold grasper shaft 138. As can be seen in theembodiment of FIGS. 9A-9B, reel 616 can include an optional groove orchannel 617 in which grasper shaft 138 can be received. Rotation of reel616 causes grasper shaft 138 to be wound onto reel 616 or unwound fromreel 616 depending on the direction of rotation. Winding of graspershaft 138 onto reel 616 corresponds to proximal retraction of implant102 (e.g., into inner shaft lumen 131), while unwinding of grasper shaft138 from reel 616 corresponds to distal advancement of implant 102(e.g., out of inner shaft lumen 131). In the embodiment of FIGS. 9A-9B,channel 617 is a helical channel that extends about the circumference ofreel 616 multiple times. In the embodiment depicted in FIG. 6B, channel617 is omitted.

In some embodiments, input gear 612 can be configured as an interruptedgear, where one or more teeth are not present such that rotation ofinput gear 612 will not cause corresponding rotation of another gear atall times. An example of such an input gear 612 is depicted in theperspective view of FIG. 6C. From the perspective depicted here, inputgear 612 has teeth 620 spaced at regular intervals on the left side 621of the radial edge of the gear. Teeth 620 are also present at regularintervals on the right side 622 of the radial edge of the gear exceptfor a region 623 where no teeth are present. A smooth surface hub 624 ispresent adjacent to this interrupted region 623. The right side 622 ofinput gear 612 is configured to engage with reel gear 614. Placement ofinterrupted region 623 is predetermined such that continuous userdepression of trigger 202 (and thus continuous rotation of pinion gear605, face gear 610, and input gear 612) does not translate intocontinuous rotation of reel gear 614. Instead, reel gear 614 will onlybe turned when engaged with the portion of input gear 612 having teeth620 and will not be turned while interrupted region 623 is traversingreel gear 614. Placement of interrupted region 623 allows for a pause inlongitudinal translation (e.g., distal and/or proximal) of grasper shaft138. Interrupted region 623 is specifically placed such thatlongitudinal translation only occurs during certain parts of thedelivery sequence.

In this embodiment, placement of switch 604 in the down positiontranslates user depression of trigger 202 into pushing of implant 102,while placement of switch 604 in the up position translates userdepression of trigger 202 into pulling of implant 102 and/or inner shaft130. In other embodiments, these switch positions can be reversed tocause the opposite motions.

FIG. 7A is a top down view depicting a cam assembly 702 of proximalcontrol device 200. Cam assembly 702 includes an outer slotted tube orcam 703, an inner slotted tube 704, and a guide member 706. Cam assemblycan be positioned within yoke 601. FIG. 7B is a perspective viewdepicting this embodiment of cam 703. Cam 703 is coupled with face gear610 such that rotation of face gear 610 also rotates cam 703. Innerslotted tube 704 is mounted within proximal control device 200 such thatit does not rotate when cam 703 rotates. Guide member 706 can beconfigured as an arm or strut member that is located within and followsboth a slot 710 in cam 703 and a slot 714 in inner tube 704. Guidemember 706 is coupled with a hub 802 (FIG. 8) located within innerslotted tube 704 that is in turn coupled with inner shaft 130. Rotationof face gear 610 causes rotation of cam 703 which in turn causes guidemember 706 to follow the path or route of slot 710 in cam 703. Becauseguide member 706 extends through slot 714 in inner tube 704, which isnot rotatable, rotation of cam 703 causes guide member 706 to move onlyin a longitudinal direction and not a radial direction.

Slot 710 can have one or more sloped slot portions and/or one or moreradial slot portions. In the embodiment depicted here, slot 710 hasmultiple sloped portions (e.g., slot portions 717 a, 717 b, and 717 c)and multiple radial portions (e.g., slot portions 719 a, 719 b, 719 c,and 719 d). Other shapes can be used as well and linked together to formthe desired path. Sloped slot portions 717 can have a constant orvariable slope, and in some embodiments these sloped slot portions canvary such that the slope reverses from positive to negative (like a“V”).

A sloped slot portion 717 can be an opening or groove in cam 703 with anon-perpendicular and non-parallel angle (with respect to longitudinalaxis 204) that moves guide member 706 along longitudinal axis 204 duringrotation. A radial slot portion 719, in most embodiments, is parallel tolongitudinal axis 204 such that rotation of cam 703 moves radial slotportion 719 with respect to guide member 706 while guide member 706 doesnot move in the longitudinal direction (proximally or distally). Radialslot portion 719 can correspond to a pause in the delivery sequencewhere trigger 202 is continuing to be depressed and other components ofdelivery device 103 are moving but inner shaft 130 remains in the samerelative position.

In FIG. 7A, guide member 706 is located at the distal most terminuswithin radial slot portion 719 a (FIG. 7B). For retraction of innershaft 130, cam 703 is rotated in counterclockwise direction 720. Whilecam 703 rotates radial slot portion 719 a past guide member 706 there isno longitudinal movement of inner shaft 130. When guide member 706reaches sloped slot portion 717 a, it begins to proximally retract alongwith inner shaft 130. This process repeats as guide member 706 movesthrough the succession of radial slot portions 719 (e.g., pauses inshaft 130 retraction) and sloped slot portions 717 (e.g., retraction ofshaft 130). In some embodiments, guide member 706 can be selectivelycoupled with outer shaft 120 to cause longitudinal movement of thatcomponent. For example, proximally retracting inner shaft 130, outershaft 120 can be proximally retracted as well, for example to allow thephysician to continue imaging the deployment process. Similarembodiments utilizing a cam assembly, that can be used with theembodiments described here, are described in the incorporated Int'lPubl. No. WO 2017/184887.

Proximal control device 200 can also be configured to rotate inner shaft130 with respect to distal control member 140 during extrusion ofimplant 102 from within inner lumen 131. FIG. 8 is a side view depictingan example embodiment of a second gear assembly 800 configured totranslate rotation of face gear 610 into rotation of hub 707, which isin turn coupled with inner shaft 130. Gear assembly 800 is locateddistal to cam assembly 702 (see FIGS. 6A and 7A). Gear assembly 800 caninclude a first gear 802 coupled with cam 703 such that rotation of cam703 causes rotation of gear 802. In this embodiment, gear 802 has anannular or ring-like shape with a first set of radially inwardlyprojecting teeth 804 and an interrupted region 806. Gear 802 can have asecond set of radially inwardly projecting teeth (not shown) with aninterrupted region that are located in a plane different from teeth 804.

Gear assembly 800 can also include translation gears 810, 812, and 814,which can also be referred to as planetary gears, which translaterotation of gear 802 to a centrally located gear 816. In this example,the first set of teeth 804 engages with gear 810, which in turn engageswith and rotates central gear 816 in a first direction. Central gear 816has an aperture in which hub 707 is rotationally secured but free toslide longitudinally. Thus, rotation of gear 802 is translated torotation of hub 707, which in turn rotates inner shaft 130. The secondset of teeth of gear 802 (not shown) engages with gear 812, which inturn is engaged with gear 814, which in turn is engaged with centralgear 816 and causes rotation of central gear 816 in the oppositedirection. Depending on the positions of the first and second sets ofteeth, and the interrupted regions in the various planes, constantrotation of annular gear 802 in one direction can translate into timedrotation of central gear 816 in the same direction, in the oppositedirection, or no rotation of central gear 816 at all.

The delivery sequence of the three stages can be described relative tocorresponding features of implant 102. Each ring-shaped structure 111and interconnect 112 is subjected to pushing by grasper 136. In someembodiments, implant 102 can be rotated by grasper 136 as well. In someembodiments, the total longitudinal push distance traveled by grasper136 (provided by reel 616) in an implant delivery is roughly equivalentto the additive circumferences of all ring-shaped structures 111 of theembodiment of implant 102. The combined movement of pushing and rotatingcan ensure that, despite lateral forces impinged on the prostaticurethra, ring-shaped structures 111 of implant 102 are laid down inplane to provide sufficient radial force to open the cavity. Eachinterconnect 112 of implant 102 is subjected to the pulling stage(without rotation) by the hub and cam. Thus, the total axial pulldistance traveled by the hub inside the cam is roughly equivalent to thetotal longitudinal length of implant 102. The pulling stage andpushing/rotation stage do not occur at the same time during the deliverysequence; they are mutually exclusive.

Proximal control device 200 can be configured so that, after all ofring-shaped structures 111 have been deployed from inner lumen 131 butprior to advancement of proximal engagement feature 115 and recess 139from within lumen 131, further deployment of implant 102 isautomatically prevented. This provides the physician with an opportunityto verify that implant 102 has been properly deployed and placed priorto releasing implant 102 from delivery device 103.

FIGS. 9A-9F are interior perspective views depicting an exampleembodiment of proximal control device 200 with a lock or lockingmechanism 900 for preventing premature release of implant 102. Lockingmechanism 900 interfaces with a groove or channel 902 in the proximallyfacing surface of face gear 610 as shown in FIGS. 9A-9B. Alongitudinally, laterally, and radially inwardly movable trackingmechanism 904 has a head portion with a projection 905 and is biaseddistally such that projection 905 presses into and tracks within groove902. As face gear 610 is rotated by pinion gear 605 (not shown),tracking mechanism 904 follows the spiral groove 902 and moves radiallyinwardly. This movement continues until implant 102 is almost fullydeployed, but proximal engagement member 115 is still retained bygrasper 136 within inner lumen 131. At this point, projection 905 entersa relatively deeper portion 906 of groove 902 (e.g., a cavity), whichsecurely captures tracking mechanism 904. Further rotation of face gear610 causes tracking mechanism 904 to move laterally or swivel in asemicircular arc to the position depicted in FIGS. 9C-9D, where an arm907 of tracking mechanism 904 is prevented from further lateral motionby a fixed body 915. Further rotation of face gear 610 is prevented,which in turn prevents rotation of all gears and prevents the user fromcontinuing to pull trigger 202.

If the physician is satisfied with placement of implant 102, then anunlock actuator or tab 910, which is accessible to the user outside ofhousing 203, is pulled proximally. Unlock tab 910 is coupled, directlyor indirectly, to the control wire 146 responsible for releasingretainer 142 as described with respect to FIGS. 2C and 2D. Thus, theproximal movement of unlock tab 910 causes retainer 142 to moveproximally and allows release of distal engagement member 114 of implant102 from delivery device 103. Unlock tab 910 can also be coupled withtracking mechanism 904 such that proximal retraction of tab 910withdraws projection 905 from within groove 902. This action unlocksdevice 200 and the user is free to continue depression of trigger 202,which in turn feeds reel 616 forward to further unwind grasper shaft 138and cause proximal engagement member 115 of implant 102 and recess 139to exit inner lumen 131 of shaft 130. At this stage both distalengagement member 114 and proximal engagement member 115 of implant 102are exposed and implant 102 is free to disengage or release from device103.

Proximal control device 200 can be configured to rotate distal controlmember 140 with respect to the other components of delivery device 103to facilitate the removal of distal engagement member 114 from distalcontrol device 140. In the embodiment depicted in FIG. 9E, a second cam940 is rotatable within body 941. Distal control member 140 (not shown)is secured to cam 940 (e.g., with a set screw) such that rotation of cam940 causes rotation of distal control member 140. Cam 940 has two slopedsurfaces 944 a and 944 b that are in contact with two rigid members(e.g., pins) 946 a and 946 b, respectively, that are fixed to body 941and located on opposite sides of cam 940. Cam 940 is rotatable butlongitudinally fixed with respect to body 941. Pulling unlock tab 910moves body 941 and members 946 a and 946 b proximally. Cam 940 cannotmove proximally so the contact of members 946 on sloped surfaces 944cause cam 940 to rotate, which in turn rotates distal control member140. Thus, the retraction of tab 910 releases retainer 142 and rotatesdistal control member 140, which uncovers distal engagement member 114of implant 102 (implant 102 is now expanded in contact with theurethra). The rotation assists in withdrawing distal engagement member114 from recess 143 of member 140 and can ensure complete disengagement.

In some embodiments, distal control member 140 has a preset bend (notshown) proximal to retainer 142. Distal control member 140 is deformedfrom this preset bent shape when attached to distal engagement member114 (e.g., as depicted in FIGS. 2B, 2G, and 2H), and thus is biased toreturn to this preset bent shape, which can also assist in thedisengagement of member 140 from implant 102 (either instead of, or inaddition to, embodiments where device 200 rotates member 140).

A stop surface 912 is present on tracking mechanism 904 that opposesanother stop surface 914 on fixed body 915. In the position of trackingmechanism 904 shown in FIG. 9B, these opposing stop surfaces 912 and 914prevent unlock tab 910 from being proximally retracted since body 915 isa separate component held in a static position (e.g., by housing 203).Lateral movement of tracking mechanism 904, e.g., in the semicirculararc, continues until stop surface 912 ceases and passes stop surface 914as shown in FIG. 9D. This feature prevents premature unlocking ofimplant 102 by proximally retracting unlock tab 910 before implant 102is sufficiently deployed.

Proximal control device 200 can also include an emergency releasemechanism that permits removal of a partially deployed implant 102 fromthe patient. Unlock tab 910 can be decoupled from tracking mechanism 904by disengaging a notch of a deflectable arm 920 from a detent 922 on thebase of tracking mechanism 904. In other embodiments the notch anddetent features can be reversed. An emergency release button 924 havinga ramped surface 925 is positioned underneath arm 920 (see FIGS. 9A-9B).Actuation, e.g., by pushing, release button 924, causes the rampedsurface 925 to deflect arm 920 upwards and decouple the notch fromdetent 922 as depicted in FIG. 9E. In this state, unlock tab 910 isdecoupled from tracking mechanism 904 and is free to be proximallyretracted even while stop surfaces 912 and 914 are in opposingpositions. Proximal retraction of unlock tab 910 retracts control wire146 and releases distal engagement member 114 of implant 102 from distalcontrol member 140. At this point, the partially deployed implant 102 isstill attached to grasper 136, which can be proximally retracted intoouter shaft 120 and then completely removed from the patient.

Example Embodiments of Delivery Methods

FIG. 10A is a flow diagram depicting an example embodiment of a method1000 of delivering implant 102 using system 100. Distal end region ofouter shaft 120 is inserted into the urethra, preferably with innershaft 130, distal control member 140, and anchor delivery member 150 inretracted states fully contained within outer shaft 120 such that nopart is extending from the open distal terminus of outer shaft 120.After advancement into the urethra, at step 1002 anchor delivery member150 is advanced distally with respect to the remainder of deliverydevice 103 (e.g., members 120, 130, and 140) and used to deploy anchor152 within the bladder. In some embodiments, deployment of anchor 152can be the inflation of one or more balloons (e.g., as depicting inFIGS. 2B, and 4H-4J) by the introduction of an inflation medium throughan injection (e.g., luer taper) port. FIG. 6A depicts tubing 650 forballoon inflation. In other embodiments deployment of anchor 152 can bethe advancement of one or more wire-form members from anchor deliverymember 150 such that they deflect into a position that opposes thebladder wall (e.g., FIGS. 4A-4G). The longitudinal positioning (e.g.,advancement and retraction) of anchor delivery member 150 and/or anywire-form members can be accomplished manually by the user manipulatinga proximal end of anchor delivery member 150 and/or any wire-formmembers either directly or with proximal control device 200.

At step 1004, anchor 152 can be held in tension against the bladder wallby exertion of a proximally directed force on device 200. Anchor 152 cantherefore provide an ordinate for system 100 from which to deployimplant 102 in an accurate location. This feature can ensure the implantis not placed too close to the bladder neck.

At 1006, distal control member 140 and inner shaft 130 can then bedistally advanced from within outer shaft 120 if they have not already(for example, step 1006 can occur prior to steps 1002 and/or 1004). Theuser can manipulate the position of proximal control device 200 with theaid of imaging (as described herein) until implant 102 is in the desiredposition. Once implant 102 is in the desired position, the implantdeployment procedure can begin. The steps for implant deployment can beperformed automatically by user actuation of proximal control device 200(e.g., actuation of trigger 202, selection of a position for switch 604,etc.), or the steps can be performed directly by hand manipulation ofeach component of delivery device 103, or by a combination of the two asdesired for the particular implementation.

In some embodiments, deployment of implant 102 from within lumen 131 isfully accomplished by (1) distally advancing grasper 136 with respect toinner shaft 130, while inner shaft 130 is not moved; while in otherembodiments, deployment of implant 102 from within inner lumen 131 isfully accomplished by (2) proximally retracting inner shaft 130 withrespect to grasper 136 while grasper 136 is not moved. In someembodiments, deployment of implant 102 is fully accomplished by (3) acombination of both movements. In still other embodiments, deployment ofimplant 102 is fully accomplished by (1), (2), or (3) in combinationwith one or more rotations of inner shaft 130, in one or more directions(e.g., clockwise or counterclockwise) with respect to distal controlmember 140.

An example embodiment of a sequence of steps 1008, 1010, and 1012 fordeploying implant 102 is described with reference to FIG. 10A and thetiming diagram of FIG. 10B. First with reference to FIG. 10A, at step1008 a first ring-shaped structure 111 a is caused to exit lumen 131 ofinner shaft 130, at step 1010 an interconnect 112 is caused to exitlumen 131, and at step 1012 a second ring-shaped structure 111 b iscaused to exit lumen 131. Steps 1010 and 1012 can be repeated for eachadditional interconnect 112 and ring-shaped structure 111 present onimplant 102.

In FIG. 10B, step 1008 begins at the far left of the timing diagram atT0. Deployment of ring-shaped structure 111 a corresponds to theduration of time marked 1008, deployment of interconnect 123 correspondsto time span 1010, and deployment of ring-shaped structure 111 bcorresponds to time span 1012. Those of ordinary skill in the art willrecognize that the differentiations between deployment of a ring-shapedstructure 111 and deployment of an interconnect 112 are approximationsas the transitions between those portions of implant 102 can be gradualand do not have to have precise demarcations.

The embodiment described with respect to FIG. 10B is for an implant withring-shaped structures 111 having opposite directions of winding (e.g.,clockwise, then counterclockwise, then clockwise, etc.). Three differentmotions are indicated in FIG. 10B. At top is rotational motion of innershaft 130 in one direction (e.g., clockwise), in the middle islongitudinal motion (e.g., proximal or distal) of one or more componentsof delivery device 103, and at bottom is rotational motion inner shaft130 in the direction opposite (e.g., counterclockwise) to that indicatedat top. In embodiments where ring-shaped structures 111 of implant 102are all wound in the same one direction, rotation of inner shaft 130will also be in only one direction.

From time T0 to T1, deployment of implant 102 is accomplished byrotating inner shaft 130, as indicated in region 1031. At the same time,in region 1032, grasper 136, and thus implant 102, is distally advancedwithout moving outer shaft 120 longitudinally (neither distally norproximally) nor rotationally, and also without longitudinally movinginner shaft 130 (neither distally nor proximally). By way of example,within proximal control device 200 the rotational movement of innershaft 130 without corresponding longitudinal movement of both innershaft 130 and outer shaft 120 is accomplished by the user depression oftrigger 202 being translated (through the yoke and pawl) into therotation of pinion gear 605 and face gear 610. Rotation of face gear 610also rotates cam 703 of cam assembly 702 (FIGS. 7A-7B) while guidemember 706 is in a radial slot portion (e.g., 719 a), and thus neitherof shafts 120 and 130 move longitudinally. Rotation of cam 703 alsocauses second gear assembly 800 (FIG. 8) to rotate inner shaft 130. Theadvancement of grasper 136 is caused by face gear 610 rotating inputgear 612, which in turn rotates reel gear 614 (FIGS. 6A-6B) and causesreel 616 to rotate and unwind grasper shaft 138 distally.

From time T1 to T2, rotation of inner shaft 130 is stopped but distaladvancement of grasper 136 continues while shafts 120 and 130 do notmove longitudinally. By way of example, within proximal control device200, user depression of trigger 202 continues and cam 703 continues torotate with guide member 706 in a radial slot portion (e.g., 719 a).Rotation of cam 703 continues to rotate annular gear 802 of second gearassembly 800, but at this point an interrupted portion (without teeth)of annular gear 802 is reached none of planetary gears 810, 812, and 814are rotated, and thus rotation of central gear 816 and inner shaft 130is stopped. In this embodiment, deployment of first ring-shapedstructure 111 a is complete at time T2.

From time T2 to T4, deployment of a first interconnect 112 takes place.In region 1033, from time T2 to T4, no distal advancement of grasper 136(and implant 102) occurs. Deployment of interconnect 112 is accomplishedby proximal retraction of both outer shaft 120 and inner shaft 130 whileholding grasper 136 in place. This causes interconnect 112 to exit innerlumen 131 of shaft 130. By way of example, in proximal control device200, user depression of trigger 202 continues and face gear 610continues to rotate, as do both cam 703 and input gear 612. Interruptedportion 623 in input gear 612 is reached and rotation of input gear 612no longer causes rotation of reel gear 614, and thus distal advancementof grasper shaft 138 is stopped. Within cam assembly 702, guide member706 transitions from a radial slot portion (e.g., 719 a) to a slopedslot portion (e.g., 717 a), and rotation of cam 703 causes guide member706 to move proximally. With guide member 706 coupled with shafts 120and 130, these shafts 120 and 130 also move proximally.

With respect to rotation of inner shaft 130, from time T2 to T3 norotation of inner shaft 130 occurs. Within proximal control device 200the interrupted portion of annular gear 802 continues and there is norotation of shaft 130 by central gear 816.

In embodiments where interconnect 112 is straight, it can be desirableto refrain from rotating shaft 130 while interconnect 112 is deployedfrom time T2 to T4. For embodiments where interconnect 112 is curved,such as the embodiment of FIGS. 1B-1D, it can be desirable to initiaterotation of inner shaft 130 during interconnect deployment. FIG. 10Bdepicts deployment for a curved interconnect 112, and from T3-T4 innershaft 130 is rotated in the opposite direction as indicated by region1034. By way of example, within proximal control device 200, userdepression of trigger 202 continues and this motion is translated toannular gear 802, which has a region with teeth that come intoengagement with the planetary gears responsible for motion of centralgear 816 in the opposite direction. Rotation of central gear 816 in theopposite direction therefore begins and inner shaft 130 is likewiserotated in the opposite direction from that of times T0 to T1, whichfacilitates deployment of interconnect 112 and begins rotation of innershaft in the direction appropriate for the oppositely wound secondring-shaped structure 111 b.

At T4, deployment of interconnect 112 is complete and deployment ofsecond ring-shaped structure 111 b begins. Proximal retraction of shafts120 and 130 is stopped as indicated by the cessation of region 1033.Distal advancement of grasper shaft 138 is restarted in region 1035 atT4, while outer shaft 120 is not moved rotationally nor longitudinally.Rotation of inner shaft 130 continues as indicated in region 1034, butinner shaft 130 is not moved longitudinally. By way of example, withinproximal control device 200, the user continues to depress trigger 202.Rotation of cam 703 continues but guide member 706 reaches a secondradial slot portion (e.g., 719 b) and proximal movement of guide member706 stops (as does retraction of shafts 120 and 130). Rotation ofcentral gear 816 continues. Interrupted portion 623 of input gear 612ceases and teeth 620 reengage with reel gear 614 causing rotation ofboth reel gear 614 and reel 616 to begin again, and thus distaladvancement of grasper shaft 138 begins as well.

These motions continue until time T5, at which point rotation of innershaft 130 is stopped. Within proximal control device 200, an interruptedportion of annular gear 802 is reached and gear 802 disengages from theplanetary gears and rotation of central gear 816 is stopped. Userdepression of trigger 202 continues from time T5-T6, the componentsoperate with similar motions as described from time T1 to T2. If anotherinterconnect 112 and ring-shaped structure 111 are present, then thesequence beginning at time T6 can be the same as that describedbeginning at time T2 and continuing to time T6. This process can repeatas needed until all ring-shaped structures 111 of implant 102 aredeployed. In some embodiments, further depression of trigger 202 can bestopped by lock mechanism 900 (FIGS. 9A-9B) to prevent prematuredeployment and release of proximal engagement portion 115.

In many embodiments described here, deployment of all of ring-shapedstructures 111 can occur with a single continuous depression of trigger202. In all of these embodiments, proximal control device 200 caninstead be configured such that repeated pulls of trigger 202 arerequired to deploy all of ring-shaped structures 111 of implant 102.

During deployment, e.g., after time T0 up until completed deployment ofthe proximal-most ring-shaped structure 112, if the physician wishes torecapture implant 102, then depression of trigger 202 can be stopped.Trigger 202 can be spring-loaded or otherwise biased to return to theoutermost position. The physician can adjust switch 604 from theposition corresponding to deployment to a different positioncorresponding to recapture. This adjustment of switch 604 will disengagepawl 603 and engage pawl 602. The physician can again depress trigger202 and that depression will translate into the reverse motion of facegear 610, which in turn translates into reverse motion of the remainderof first gear assembly 600, cam 703, and second gear assembly 800. Forexample, if switch 604 is adjusted at any time between times T0 and T6,then the next depression of trigger 202 will cause the sequence ofevents to be reversed going from right to left in FIG. 10B. Becausethese motions are merely a reversal of that already described, they willnot be repeated here.

If the physician is satisfied with deployment, then at 1014 distalengagement portion 114 and proximal engagement portion 115 of implant102 can be released from distal control member 140 and grasper 136,respectively. By way of example, in proximal control device 200 thephysician can pull tab 910 to permit trigger 202 to be depressed therest of the way, which in turn can deploy proximal engagement portion115 of implant 102, either by distal advancement of grasper 136,proximal retraction of shafts 120 and 130, or both. Tab 910 can becoupled with control wire 146 and the pulling of tab 910 can pull wire146 and remove retainer 142 from distal engagement portion 114.

Anchor 152 can then be recaptured (e.g., deflation of the balloon orretraction of the wire-form members) and withdrawn into anchor deliverymember 150 if desired. Anchor delivery member 150, distal control member140, and inner shaft 130 can be retracted into outer shaft 120 and thenwithdrawn from the urethra.

The embodiments described herein are restated and expanded upon in thefollowing paragraphs without explicit reference to the figures. In manyexample embodiments, a system for delivering an implantable device isprovided, where the system includes a delivery device including: anouter tubular member; an inner tubular member having a first inner lumenand a second inner lumen, the inner tubular member being slidable withinthe outer tubular member, where the first inner lumen is adapted tohouse an elongate grasper member configured to releasably couple with aproximal portion of an implant; and a distal control member slidablewithin the second inner lumen, where the distal control member includesa retainer configured to releasably couple with a distal portion of theimplant.

In some embodiments, the implant is configured to maintain a prostaticurethra in an at least partially open state. In some embodiments, theimplant has a body including first and second ring-shaped structures andan interconnect that extends between the first and second ring-shapedstructures. The body of the implant can be only a single wire. Theimplant can include a distal engagement member configured to releasablycouple with the retainer and/or a proximal engagement member configuredto releasably couple with the elongate grasper member. In someembodiments, the implant includes a wire-like distal engagement memberthat extends proximally away from a distal-most portion of the implantand/or a wire-like proximal engagement member. In some embodiments, thefirst ring-shaped structure can be the distal-most ring-shaped structureof the implant and has a relatively smaller width than the secondring-shaped structure.

In some embodiments, the inner tubular member is slidable and rotatablewith respect to the distal control member while the retainer isreleasably coupled with the distal portion of the implant. The systemcan further include an elongate member coupled with the retainer andhaving a proximal end that is manipulatable by a user to permit releaseof the distal portion of the implant from the retainer. In someembodiments, the retainer is tubular and adapted to slide along thedistal control member. The distal control member can include a recessadapted to receive the distal portion of the implant and the retainercan be movable to uncover the recess while the distal portion of theimplant is received within the recess. In some embodiments the retainerincludes a slot through which the implant can pass.

In some embodiments, the system includes an elongate anchor member. Theelongate anchor member can include an anchor configured to contact abladder wall. The anchor can be an inflatable balloon or multipleinflatable balloons. In some embodiments, the elongate anchor memberincludes a wire-form member having a portion configured to automaticallydeflect when deployed.

In some embodiments, the elongate grasper member includes a recessconfigured to releasably couple with the proximal portion of an implant.In some embodiments, the system is configured such that the proximalportion of the implant is free to release from the recess of theelongate grasper member when the recess is unconstrained by the firstinner lumen.

In some embodiments, a proximal control device is included and coupledwith a proximal end region of the delivery device. The proximal controldevice can be manipulatable by a user to control deployment of theimplant from the delivery device. In some embodiments, the proximalcontrol device includes a housing and is configured to distally advancethe elongate grasper member with respect to the housing and the innertubular member, and/or is configured to proximally retract and rotatethe inner tubular member with respect to the housing and the distalcontrol member, and/or is configured to proximally retract the outertubular member with respect to the housing.

In some embodiments, the proximal control device includes: a useractuator; a first gear assembly coupled with the user actuator; a camassembly coupled with the first gear assembly; and a second gearassembly coupled with the cam assembly. In some embodiments, the firstgear assembly is configured to control longitudinal movement of theelongate grasper member, the cam assembly is configured to controllongitudinal movement of the inner tubular member, and/or the secondgear assembly is configured to control rotation of the inner tubularmember.

In many embodiments, a system for delivering an implantable device isprovided, where the system includes: a delivery device including a firstelongate member having an inner lumen, an elongate grasper memberslidable within the inner lumen and configured to hold a proximalportion of an implant, and a distal control member configured to hold adistal portion of the implant; and a proximal control device coupledwith a proximal end region of the delivery device, the proximal controldevice including a user actuator and a housing.

In some embodiments, the proximal control device includes a first gearassembly within the housing, the proximal control device beingconfigured to translate movement of the user actuator into movement inthe first gear assembly. In some embodiments, the proximal controldevice includes a switch that selects between movement of the first gearassembly in a first direction and movement of the first gear assembly ina second direction. In some embodiments, the user actuator is coupledwith a yoke that is coupled with a first pawl and a second pawl. Theswitch selectively can engage either the first pawl or the second pawlwith a pinion gear. The proximal control device can be configured suchthat rotation of the pinion gear causes rotation of a face gear. Theproximal control device can be configured such that rotation of the facegear causes rotation of a reel coupled with the elongate grasper member.

In some embodiments, the system further includes an input gear engagedwith the face gear and a reel gear engaged with the input gear, the reelgear being coupled with or integrated with the reel. In someembodiments, the input gear is an interrupted gear, and rotation of thereel gear by the input gear causes rotation of the reel and longitudinalmovement of the elongate grasper member. In some embodiments, movementof the first gear assembly in the first direction causes distal movementof the elongate grasper member, and movement of the first gear assemblyin the second direction causes proximal movement of the elongate graspermember.

In some embodiments, the proximal control device includes a cam assemblywithin the housing, the proximal control device being configured totranslate movement of the user actuator into movement in the camassembly. The cam assembly can be coupled with the first elongate memberand can be configured to move the first elongate member proximally withrespect to the housing. In some embodiments, the cam assembly includes arotatable cam having a slot, the first elongate member being coupledwith a guide member received within the slot. In some embodiments, theslot includes a sloped slot portion and a radial slot portion. The camassembly can include an inner tube having a longitudinal slot with theguide member received in the longitudinal slot.

In some embodiments, the first gear assembly includes a face gear havinga first set of teeth that engage with teeth of another gear in the firstgear assembly, where the face gear is coupled with the cam assembly suchthat movement of the face gear causes movement in the cam assembly.

In some embodiments, the proximal control device includes a second gearassembly and movement in the cam assembly can cause movement in thesecond gear assembly. The second gear assembly can be coupled with thefirst elongate member and can be configured to rotate the first elongatemember with respect to the housing. The second gear assembly can includea central gear having an aperture configured to receive the firstelongate member such that rotation of the central gear causes rotationof the first elongate member. In some embodiments, the second gearassembly includes an annular gear coupled with the cam assembly andcoupled with the central gear by way of a planetary gear assembly. Theannular gear can engage the planetary gear assembly such that rotationof the annular gear in a first direction causes first directionalrotation of the central gear and rotation of the annular gear in asecond direction causes second directional rotation of the central gear,the first directional rotation of the central gear being opposite to thesecond directional rotation.

In some embodiments, the proximal control device includes a releasablelock mechanism that prevents the proximal portion of the implant held bythe elongate grasper member from exiting the inner lumen. In someembodiments, the lock mechanism includes a movable tracking mechanismthat interfaces with a groove in a face gear of the first gear assembly,the proximal control device configured such that movement of the facegear moves the tracking mechanism as the implant exits the inner lumen.The proximal control device can be configured such that the trackingmechanism is prevented from further motion prior to the proximal portionof the implant exiting the inner lumen.

In some embodiments, the proximal control device includes a releasestructure configured to be actuated by a user, where the releasestructure is configured to disengage the tracking mechanism from theface gear to allow the proximal portion of the implant to exit the innerlumen. The release structure can be a pull tab and can be coupled withthe elongate grasper member.

In many embodiments, a method of delivering an implant is provided thatincludes: advancing a delivery device within a body lumen of a patient,where the delivery device includes as first tubular member housing animplant, a distal control member slidable within the first tubularmember and releasably coupled with a distal portion of the implant, andan elongate grasper member slidable within the first tubular member andreleasably coupled with a proximal portion of the implant; causingrelative motion between the elongate grasper member and the firsttubular member to expose at least a portion of the implant from withinthe first tubular member; and releasing the distal portion of theimplant from the distal control member and the proximal portion of theimplant from the elongate grasper member.

In some embodiments, the body lumen is a prostatic urethra of a human.In some embodiments, upon release of the distal portion and the proximalportion, the implant is released from the delivery device in a stateadapted to maintain the prostatic urethra in an at least partially openstate.

In some embodiments, the implant has a body including first and secondring-shaped structures and an interconnect that extends between thefirst and second ring-shaped structures and causing relative motion caninclude distally advancing the elongate grasper member. In someembodiments, the method further includes rotating the first tubularmember in a first direction with respect to the distal control memberduring exposure of the first ring-shaped structure from the firsttubular member. In some embodiments, the method further includesrotating the first tubular member in a second direction with respect tothe distal control member during exposure of the second ring-shapedstructure from the first tubular member, the second direction beingopposite the first direction. Rotation of the first tubular member inthe first and second directions can occur while the distal controlmember is releasably coupled with the distal portion of the implant.

In some embodiments, the method further includes proximally retractingthe first tubular member with respect to the elongate grasper member andthe distal control member to expose the interconnect from the firsttubular member. In some embodiments, the method further includesrotating the first tubular member while proximally retracting the firsttubular member. In these embodiments, the interconnect can be curved.

In some embodiments, a retainer couples the distal portion of theimplant to the distal control member, and the method includes releasingthe retainer to release the distal portion of the implant from thedistal control member.

In some embodiments, the method further includes exposing the proximalportion of the implant from within the first tubular member to releasethe proximal portion of the implant from the elongate grasper member.

In some embodiments, the method further includes anchoring the deliverydevice against a wall of a bladder before causing relative motionbetween the elongate grasper member and the first tubular member. Insome embodiments, anchoring the delivery device includes inflating aballoon in the bladder.

In some embodiments, a proximal control device is coupled with aproximal end region of the delivery device, and the method includesmoving a user actuator of the proximal control device by the user, wheremoving the user actuator causes motion in a first gear assembly of theproximal control device. In some embodiments, the first gear assemblycauses the elongate grasper member to distally advance with respect tothe first tubular member. In some embodiments, the first gear assemblycauses movement in a cam assembly and a second gear assembly. In someembodiments, movement in the cam assembly causes intermittent retractionof the first tubular member with respect to the distal control member.In some embodiments, movement in the second gear assembly causesintermittent rotation of the first tubular member with respect to thedistal control member.

In some embodiments, the user actuator is a first user actuator, and themethod includes actuating a second user actuator of the proximal controldevice. In some embodiments, actuating the second user actuator unlocksa lock mechanism and permits release of the distal portion of theimplant from the distal control member and the proximal portion of theimplant from the elongate grasper member. In some embodiments, actuatingthe second user actuator removes a retainer from the distal portion ofthe implant and rotates the distal control member to cause the distalportion of the implant to disengage from the distal control member.

In some embodiments, the first tubular member is an inner tubular memberslidably received within an outer tubular member of the delivery device.

All features, elements, components, functions, and steps described withrespect to any embodiment provided herein are intended to be freelycombinable and substitutable with those from any other embodiment. If acertain feature, element, component, function, or step is described withrespect to only one embodiment, then it should be understood that thatfeature, element, component, function, or step can be used with everyother embodiment described herein unless explicitly stated otherwise.This paragraph therefore serves as antecedent basis and written supportfor the introduction of claims, at any time, that combine features,elements, components, functions, and steps from different embodiments,or that substitute features, elements, components, functions, and stepsfrom one embodiment with those of another, even if the followingdescription does not explicitly state, in a particular instance, thatsuch combinations or substitutions are possible. It is explicitlyacknowledged that express recitation of every possible combination andsubstitution is overly burdensome, especially given that thepermissibility of each and every such combination and substitution willbe readily recognized by those of ordinary skill in the art.

As used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural referents unless the context clearly dictatesotherwise

While the embodiments are susceptible to various modifications andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that these embodiments are not to be limited to the particularform disclosed, but to the contrary, these embodiments are to cover allmodifications, equivalents, and alternatives falling within the spiritof the disclosure. Furthermore, any features, functions, steps, orelements of the embodiments may be recited in or added to the claims, aswell as negative limitations that define the inventive scope of theclaims by features, functions, steps, or elements that are not withinthat scope.

What is claimed is:
 1. A system for delivering an implantable device,comprising: a delivery device comprising a first elongate member havingan inner lumen, an elongate grasper member slidable within the innerlumen and configured to hold a proximal portion of an implant, and adistal control member configured to hold a distal portion of theimplant; and a proximal control device coupled with a proximal endregion of the delivery device, the proximal control device comprising auser actuator and a housing.
 2. The system of claim 1, wherein theproximal control device comprises a first gear assembly within thehousing, the proximal control device being configured to translatemovement of the user actuator into movement in the first gear assembly.3. The system of claim 1, wherein the proximal control device comprisesa switch that selects between movement of the first gear assembly in afirst direction and movement of the first gear assembly in a seconddirection.
 4. The system of claim 3, wherein the user actuator iscoupled with a yoke that is coupled with a first pawl and a second pawl.5. The system of claim 4, wherein the switch selectively engages eitherthe first pawl or the second pawl with a pinion gear.
 6. The system ofclaim 5, wherein the proximal control device is configured such thatrotation of the pinion gear causes rotation of a face gear.
 7. Thesystem of claim 6, wherein the proximal control device is configuredsuch that rotation of the face gear causes rotation of a reel coupledwith the elongate grasper member.
 8. The system of claim 7, furthercomprising: an input gear engaged with the face gear; and a reel gearengaged with the input gear, the reel gear coupled with or integratedwith the reel.
 9. The system of claim 8, wherein the input gear is aninterrupted gear, and wherein rotation of the reel gear by the inputgear causes rotation of the reel and longitudinal movement of theelongate grasper member.
 10. The system of claim 3, wherein movement ofthe first gear assembly in the first direction causes distal movement ofthe elongate grasper member, and wherein movement of the first gearassembly in the second direction causes proximal movement of theelongate grasper member.
 11. The system of claim 2, wherein the proximalcontrol device comprises a cam assembly within the housing, the proximalcontrol device being configured to translate movement of the useractuator into movement in the cam assembly.
 12. The system of claim 11,wherein the cam assembly is coupled with the first elongate member. 13.The system of claim 12, wherein the cam assembly is configured to movethe first elongate member proximally with respect to the housing. 14.The system of claim 13, wherein the cam assembly comprises a rotatablecam having a slot, the first elongate member being coupled with a guidemember received within the slot.
 15. The system of claim 14, wherein theslot comprises a sloped slot portion and a radial slot portion.
 16. Thesystem of claim 14, wherein the cam assembly comprises an inner tubehaving a longitudinal slot with the guide member received in thelongitudinal slot.
 17. The system of claim 11, wherein the first gearassembly comprises a face gear having a first set of teeth that engagewith teeth of another gear in the first gear assembly, wherein the facegear is coupled with the cam assembly such that movement of the facegear causes movement in the cam assembly.
 18. The system of claim 11,wherein the proximal control device comprises a second gear assembly.19. The system of claim 18, wherein movement in the cam assembly causesmovement in the second gear assembly.
 20. The system of claim 19,wherein the second gear assembly is coupled with the first elongatemember and is configured to rotate the first elongate member withrespect to the housing.
 21. The system of claim 20, wherein the secondgear assembly comprises a central gear having an aperture configured toreceive the first elongate member such that rotation of the central gearcauses rotation of the first elongate member.
 22. The system of claim21, wherein the second gear assembly comprises an annular gear coupledwith the cam assembly and coupled with the central gear by way of aplanetary gear assembly.
 23. The system of claim 22, wherein the annulargear engages the planetary gear assembly such that rotation of theannular gear in a first direction causes first directional rotation ofthe central gear and rotation of the annular gear in a second directioncauses second directional rotation of the central gear, the firstdirectional rotation of the central gear being opposite to the seconddirectional rotation.
 24. The system of claim 2, wherein the proximalcontrol device comprises a releasable lock mechanism that prevents theproximal portion of the implant held by the elongate grasper member fromexiting the inner lumen.
 25. The system of claim 24, wherein the lockmechanism comprises a movable tracking mechanism that interfaces with agroove in a face gear of the first gear assembly, the proximal controldevice configured such that movement of the face gear moves the trackingmechanism as the implant exits the inner lumen.
 26. The system of claim25, wherein the proximal control device is configured such that thetracking mechanism is prevented from further motion prior to theproximal portion of the implant exiting the inner lumen.
 27. The systemof claim 26, wherein the proximal control device comprises a releasestructure configured to be actuated by a user, wherein the releasestructure is configured to disengage the tracking mechanism from theface gear to allow the proximal portion of the implant to exit the innerlumen.
 28. The system of claim 27, wherein the release structure is apull tab.
 29. The system of claim 27, wherein the release structure iscoupled with the elongate grasper member.
 30. The system of claim 1,further comprising the implant.